| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 4 Symbols <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 5 Conventions 6 Overview of reference material production 6.1 General 6.2 Summary of project design <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 6.3 Acquisition of starting material <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 6.4 Feasibility studies 6.5 Reference material processing 6.6 Homogeneity assessment 6.7 Stability assessment <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 6.8 Choice of measurement procedures 6.9 Metrological traceability 6.10 Characterization and uncertainty evaluation 6.11 Commutability assessment 6.12 Transport issues <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 6.13 Value assignment 6.14 Stability monitoring 6.15 Reference materials produced in repeated batches 7 Assessment of homogeneity 7.1 Preamble <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 7.2 Need for an experimental homogeneity study <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 7.3 Properties to be studied 7.4 Statistically valid sampling schemes 7.4.1 Minimum number of units for a homogeneity study <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 7.4.2 Use of statistical power analysis 7.4.3 Sampling strategies for a homogeneity study <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 7.5 Choice and conduct of the measurement procedure for a homogeneity study 7.5.1 Choice of measurement procedure 7.5.2 Conduct of measurements for homogeneity studies <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 7.6 Homogeneity study designs 7.6.1 Objective of a homogeneity study <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 7.6.2 The basic homogeneity study design \u2013 measurement in a single run <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 7.6.3 Randomized block design 7.6.4 Balanced nested design 7.6.5 Alternative strategies <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 7.7 Evaluating a homogeneity study 7.7.1 Initial inspection for measurement trends and outliers <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 7.7.2 Inspection for processing trends 7.7.3 Evaluation of the between-unit term \u2013 basic design <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 7.7.4 Evaluation of the between-unit term \u2013 randomized block design <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 7.7.5 Evaluation of the between-unit term \u2013 balanced nested design 7.7.6 Other homogeneity designs and alternative estimation methods <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 7.8 Insufficient repeatability of the measurement procedure 7.9 Within-unit homogeneity 7.9.1 Assessing the need for within-unit homogeneity study 7.9.2 Testing for significant within-unit heterogeneity <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 7.9.3 Assessing minimum sample size <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 7.10 Check for sufficient homogeneity <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 7.11 Uncertainty evaluation from homogeneity studies 8 Assessment and monitoring of stability 8.1 Preamble <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 8.2 Assessment of stability 8.2.1 Requirement for stability assessment 8.2.2 Types of (in)stability <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 8.2.3 General methods for assessment of stability 8.2.4 Need for experimental study of stability <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 8.3 Classification of stability studies 8.3.1 General 8.3.2 Classification according to conditions of measurement <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 8.3.3 Classification according to stability study duration and conditions 8.3.4 Classification by study objective <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 8.3.5 Designs for different storage and treatment conditions <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 8.4 General requirements for effective stability studies 8.4.1 Overview of requirements 8.4.2 Selection of RM units 8.4.3 Suitable measurement procedure(s) for stability studies 8.4.4 Appropriate experimental design <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | 8.5 Evaluation of stability study results 8.5.1 General considerations for stability study data treatment <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | 8.5.2 The basic stability study: multiple points in time at a single storage condition <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | 8.5.3 Isochronous designs <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | 8.5.4 Accelerated stability studies with multiple exposure conditions <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | 8.5.5 Additional sources of random variation in stability studies 8.6 Action on finding a significant trend in a stability study <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | 8.7 Uncertainty evaluation from stability studies 8.7.1 General considerations for uncertainty evaluation from stability studies 8.7.2 Sources of uncertainty in predicted change over time <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | 8.7.3 Estimation of stability uncertainties in the absence of significant trends 8.7.4 Evaluation of stability uncertainties in the case of a known significant trend <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | 8.8 Estimation of storage lifetime (\u201cshelf life\u201d) from a stability study 8.9 Instructions for use related to management of stability 8.10 Stability monitoring 8.10.1 Requirements for monitoring <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | 8.10.2 Choice of initial monitoring point and monitoring interval(s) <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | 8.10.3 Experimental approaches and evaluation for stability monitoring <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | 9 Characterization of the material 9.1 Preamble <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | 9.2 Establishing metrological traceability 9.2.1 Principle 9.2.2 Metrological references <\/td>\n<\/tr>\n | ||||||
| 59<\/td>\n | 9.2.3 Types of measurands 9.2.4 Effect of sample preparation or pre-treatment <\/td>\n<\/tr>\n | ||||||
| 60<\/td>\n | 9.2.5 Verification of traceability 9.3 Characterization using a single reference measurement procedure (as defined in ISO\/IEC Guide 99) in a single laboratory 9.3.1 Characterization by a reference measurement procedure without direct comparison with a CRM of the same kind <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | 9.3.2 Characterization by value transfer from a reference material to a closely matched candidate reference material using a single measurement procedure performed by one laboratory <\/td>\n<\/tr>\n | ||||||
| 62<\/td>\n | 9.3.3 Selection of RM units for single-laboratory characterization 9.3.4 Formulation methods <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | 9.4 Characterization of a non-operationally defined measurand using two or more methods of demonstrable accuracy in one or more competent laboratories 9.4.1 Concept <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | 9.4.2 Study design <\/td>\n<\/tr>\n | ||||||
| 65<\/td>\n | 9.4.3 Evaluation <\/td>\n<\/tr>\n | ||||||
| 66<\/td>\n | 9.4.4 Single-laboratory multi-method studies 9.5 Characterization of an operationally defined measurand using a network of competent laboratories 9.5.1 Concept <\/td>\n<\/tr>\n | ||||||
| 67<\/td>\n | 9.5.2 Study setup 9.5.3 Evaluation 9.6 Purity 9.6.1 General 9.6.2 Direct determination of purity <\/td>\n<\/tr>\n | ||||||
| 68<\/td>\n | 9.6.3 Indirect determination of purity <\/td>\n<\/tr>\n | ||||||
| 69<\/td>\n | 9.7 Ordinal scales 9.8 Nominal properties including identity 9.9 Characterization of non-certified values 10 Evaluating measurement uncertainty 10.1 Basis for evaluating the uncertainty of a property value of a CRM <\/td>\n<\/tr>\n | ||||||
| 70<\/td>\n | 10.2 Basic model for a batch characterization <\/td>\n<\/tr>\n | ||||||
| 71<\/td>\n | 10.3 Uncertainty sources 10.4 Coverage intervals and factors <\/td>\n<\/tr>\n | ||||||
| 72<\/td>\n | Annex A (informative) Design and evaluation of studies for the characterization of a method-independent measurand using two or more methods of demonstrable accuracy in one or more competent laboratories <\/td>\n<\/tr>\n | ||||||
| 83<\/td>\n | Annex B (informative) Statistical approaches <\/td>\n<\/tr>\n | ||||||
| 94<\/td>\n | Annex C (informative) Examples <\/td>\n<\/tr>\n | ||||||
| 104<\/td>\n | Annex D (informative) Measurement uncertainty evaluation <\/td>\n<\/tr>\n | ||||||
| 105<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Reference materials. Approaches for characterization and assessment of homogeneity and stability<\/b><\/p>\n |